NCT04609514

Learn to Quit-HIV Pilot Study

Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study team will conduct a feasibility, acceptability, and preliminary efficacy trial comparing Learn to Quit-HIV (n=30) to an app based on U.S. Clinical Practice Guidelines only (NCI QuitGuide; n=30) among HIV-positive smokers. Both apps will be integrated with NRT and ongoing HIV clinical care.

Conditions

• HIV/AIDS
• Smoking Cessation
• Tobacco Use Disorder

Interventions

Type	Name	Description
DEVICE	Learn to Quit-HIV	A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation.
BEHAVIORAL	QuitGuide	A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
DRUG	Nicotine patch	All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches.
BEHAVIORAL	Smartphone coaching	All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app.

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2020-10-30
• Last updated: 2023-10-19
• Results posted: 2023-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study